Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 1:27 PM
Study NCT ID:
NCT01369459
Status:
COMPLETED
Last Update Posted:
2015-08-05
First Post:
2011-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C073578', 'term': 'MIP protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-03', 'studyFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2011-06-08', 'lastUpdatePostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mini International Neuropsychiatric Interview (MINI) Version 5.0', 'timeFrame': 'Follow-up in 3 months', 'description': 'MINI is a structured diagnostic interview that assesses DSM-IV diagnoses in adolescents and is designed for administration by lay interviewers. Adolescents and caregivers will complete the Inattentive and Hyperactive/Impulsive scales.'}], 'secondaryOutcomes': [{'measure': 'Behavior Rating Inventory of Executive Function (BRIEF)', 'timeFrame': 'Follow-up at 3-months', 'description': 'The BRIEF is a parent-report measure of behavioral problems linked to executive functioning and commonly observed in ADHD youth. The BRIEF has been validated on ADHD outpatient samples and teens with mixed clinical diagnoses. This study will use 4 scales: Inhibition, Behavioral Shift, Emotional Control, Plan/Organize.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Comorbid', 'ADHD', 'SUD', 'ASU'], 'conditions': ['Attention Deficit Hyperactivity Disorder', 'Attention Deficit Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this project is to develop and test a brief protocol designed to systematically integrate pharmacological interventions for Attention Deficit Hyperactivity Disorder (ADHD) into behavioral treatment services for adolescent substance users with co-morbid ADHD in everyday care. Primary study aims will yield proof-of-concept data on MIP feasibility and fidelity in usual care and evidence of MIP impact on psychiatric and behavioral services utilization, medication acceptance and compliance, and satisfaction with treatment services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 13-17 years\n* Caregiver able to participate in treatment\n* One day of alcohol use to intoxication or illegal drug use in the past 30 days (or 30 days prior to living in a controlled environment)\n* endorsement of one or more DSM-IV symptoms of Substance Use or Alcohol Dependence/Abuse\n* meet ASAM criteria for outpatient substance use treatment\n* meet DSM-IV criteria for ADHD (with or without onset prior to age 7)\n* not enrolled in any behavioral treatment\n\nExclusion Criteria:\n\n* MDD\n* Bipolar Disorder\n* Mental Retardation\n* PDD\n* medical or psychiatric illness requiring hospitalization\n* current psychotic features\n* currently suicidal'}, 'identificationModule': {'nctId': 'NCT01369459', 'acronym': 'MIP', 'briefTitle': 'Medication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'The National Center on Addiction and Substance Abuse at Columbia University'}, 'officialTitle': 'Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD', 'orgStudyIdInfo': {'id': 'CASA2011MIP'}, 'secondaryIdInfos': [{'id': '1R21DA031305-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21DA031305-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Family Counseling with MIP Protocol', 'description': 'We intend for MIP to be a 5-session, family-based protocol delivered during the early portion of ASU treatment. MIP will contain three elements deemed essential for integrating pharmacological interventions into outpatient behavioral treatment for youth: (1) standardized psychiatric assessment and family-focused psychoeducation about the target problem; (2) an approved medication regimen with demonstrated efficacy for comorbid populations; (3) family-based interventions for medication acceptance and coordination of psychiatric and behavioral services. MIP will incorporate research-proven interventions from each of these core areas.', 'interventionNames': ['Behavioral: MIP Protocol']}, {'type': 'NO_INTERVENTION', 'label': 'Historical Control'}], 'interventions': [{'name': 'MIP Protocol', 'type': 'BEHAVIORAL', 'description': 'We intend for MIP to be a 5-session, family-based protocol delivered during the early portion of ASU treatment. MIP will contain three elements deemed essential for integrating pharmacological interventions into outpatient behavioral treatment for youth: (1) standardized psychiatric assessment and family-focused psychoeducation about the target problem; (2) an approved medication regimen with demonstrated efficacy for comorbid populations; (3) family-based interventions for medication acceptance and coordination of psychiatric and behavioral services. MIP will incorporate research-proven interventions from each of these core areas.', 'armGroupLabels': ['Family Counseling with MIP Protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10009', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Roberto Clemente Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Aaron T Hogue, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The National Center on Addiction and Substance Abuse at Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The National Center on Addiction and Substance Abuse at Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Adolescent & Family Research', 'investigatorFullName': 'Aaron Hogue', 'investigatorAffiliation': 'The National Center on Addiction and Substance Abuse at Columbia University'}}}}